Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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Mission-Driven Professionals And Students Build America's Supply Chains

Tales of purpose-led careers that bring innovations to business leaders and opportunities to university students. They inspire us. Chief Editor Louis Garguilo documents two such professionals who have combined to help domestic manufacturing organizations locate each other and power their operations, and to get students involved in the industry.

GUEST COLUMNISTS

Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
June 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.
Reshoring Pressure Meets Manufacturing Reality
U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.
CDMO Live Europe 2026: Partnerships For An Uncertain World
112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.
Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
Senior pharma leaders from Pfizer, Bayer, BioNTech and others debunk dual sourcing myths and reveal what separates strategic CDMO partnerships from transactional ones.
Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

PHARMA OUTSOURCING WHITE PAPERS

What FDA CRLs Reveal About Method Validation
FDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.

Leveraging Integrated Electronic Laboratory Notebook And Inventory Systems
Integrating lab notebooks with inventory and asset tracking boosts accuracy and traceability. Real-time visibility cuts errors, speeds decisions, and supports compliant, scalable pharma development.
Digital Innovation And Sustainability Are Redefining Biomanufacturing
Next Generation Manufacturing (NGM) integrates advanced process design, digital innovation, and strategic facility planning to facilitate agile, efficient, and sustainable biopharmaceutical production.
Digital Standardization: Accelerating Gene Therapy Tech Transfer With Confidence And Compliance
Fragmented, manual data practices slow tech transfer and increase risk; centralized digital CMC systems standardize workflows, improve transparency, and accelerate onboarding while maintaining compliance.
Accelerating An Innovative High Potency Oncology Therapy To Market
Learn how disciplined containment, proactive risk management, and collaboration accelerate complex oncology programs under tight timelines while protecting quality, safety, and global launch readiness.
A Shift Towards Biofluorescent Particle Counters In Manufacturing
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.